The US authorities are turning up the heat on Icelandic generic drugmaker Actavis over manufacturing problems at the New Jersey plant which makes its recalled Digitek brand of the cardiac drug digoxin.
In the latest development the US Department of Justice (DoJ) filed a complaint on behalf of the Food and Drug Administration (FDA) seeking a permanent injunction on the business activities of the company’s Actavis Totowa LLC subsidiary in the US.
“Recently, the defendants informed FDA that they would like to restart manufacturing drug products,” said the DoJ in a statement.
“However, Actavis has not demonstrated to FDA that it can do this in compliance with the Good Manufacturing Practice [GMP] requirements.”
Back in April, an FDA inspection of the facility in Little Falls revealed several documentation issues that were not compliant with GMP standards.
Most serious was the discovery that batches of Digitek had been produced at the plant after tests revealed that the tablets contained double the amount of active pharmaceutical ingredient (API), potentially putting patients at risk of serious and even fatal reactions.
“Double dose digoxin tablets can cause digitalis toxicity and result in cardiac instability, bradycardia and death among other things,” said the DoJ.
The FDA ordered a Class I recall of batches of Digitek made at the facility, and that was followed in August by a voluntary recall of all the other medicines made at the plant.
The DoJ lawsuit is trying to prevent Actavis Totowa and its parent Actavis Inc, along with senior managers Sigurdur Olafsson and Douglas Boothe, from manufacturing and distributing generic drug products. The complaint states that Actavis Totowa failed to resolve violations despite repeated written warnings and five inspections of the Little Falls plant over the last three years.
In addition, the FDA warned Actavis against producing products containing ergotamine tartrate, which the agency considers an unapproved new drug. But despite the warning, the company continued to manufacture these unapproved products, claims the DoJ.
In response, Actavis issued a statement saying that it “continues to work to address compliance issues,” and is “confident that the actions it has taken to remedy the compliance and manufacturing issues at Actavis Totowa will exceed FDA’s expectations.”
John LaRocca, Actavis’ chief legal officer, commeted: “Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted.”
The FDA is itself under fire in the case. Representatives John Dingell and Bart Stupak sent a letter to the agency last month asking for information from Commissioner Andrew von Eschenbach about the Actavis Totowa recall, as part of a wider probe into the agency’s competence.
The representatives are seeking extensive documentation from the FDA, covering all Actavis products that have been approved for sale since 1 January 2003. They are also seeking documentation of all Actavis products imported to the US since this date, regardless of when they were approved.